Why Comprehensive Testing?
Diagnostic tests that are accurate and scalable are the key to ending the pandemic.
From detecting acute infection, to monitoring immune response, to contact tracing across communities, slowing the spread COVID-19 requires a full suite of tests, tools, and diagnostic solutions.
Infection identification is crucial but is only part of the picture. As SARS-CoV-2 infection progresses within the body, the patient’s biomarker levels—including viral RNA and antibodies—can change significantly.* Uncovering these blind spots and understanding and monitoring these changes is vital for assessing people’s recovery and tracking the virus’s prevalence in our communities.
Siemens Healthineers is proud to offer a comprehensive portfolio of real-time PCR testing and total antibody testing, all specifically engineered to give public health officials and healthcare organizations the full breadth of information they need to reduce the spread of SARS-CoV-2.
And we are ready to immediately—and fully—meet the supply needs of laboratories everywhere.
Identifying Acute Infections
Using real-time PCR to detect RNA from the novel coronavirus that causes COVID-19, the FTD SARS-CoV-2 Assay is used to diagnosis current cases of COVID-19.
- Single-well, dual target assay covering highly conserved regions within ORF1ab and N gene
- Validated specimen types include nasopharyngeal and oropharyngeal swabs
- Dual target design reduces inconclusive results and the need for repeat testing
- In silico analysis of 1,227,861 complete sequences for the ORF1ab target and 1,225,677 complete sequences for the N gene target of SARS-CoV-2 from the GISAID database (https://www.gisaid.org/).
A recent FDA study ranking the top-performing SARS-CoV-2 PCR assays notes that the Siemens Healthineers assay has high analytical sensitivity. Click here to see the report. produced no cross-reactivity with MERS-CoV
Monitoring Immune Response
Antibody testing, also known as serology testing, helps determine if a patient has had a recent or past SARS-CoV-2 infection. It can also be used to monitor the body’s immune response to the virus.
The Siemens Healthineers SARS-CoV-2 Total (COV2T) Assay can be used effectively for broad population testing.
The Siemens Healthineers Atellica® IM† and the ADVIA Centaur®§ SARS-CoV-2 IgG (sCOVG) assays measure IgG antibodies to SARS-CoV-2 in the blood, helping clinicians assess the level of an individual's immune response over time. Siemens Healthineers also offers SARS-CoV-2 IgG assays for the Dimension EXL and Dimension Vista platforms.†
Managing Critical Cases
Severe cases of COVID-19 are often associated with cytokine storm, a dysregulated systemic immune response to the virus that can cause widescale cellular and organ damage. Interleukin-6 (IL-6) testing for patients experiencing a severe inflammatory response to SARS-CoV-2 can indicate the development of cytokine storm.
- An early indicator of inflammatory response
- Aids in identifying early warning signs of potentially deadly cytokine storm
- Help determine risk of needing intubation with mechanical ventilation
To learn more about IL-6 testing and the dangers of cytokine storm, visit this page.
Know the Testing Instruments
Siemens Healthineers is committed to making high performance SARS-CoV-2 testing solutions accessible for all laboratories. Our SARS-CoV-2 Testing Instrument program provides easy access for customers in need of a new analyzer platform to adopt the highly accurate SARS-CoV-2 PCR and serology assays from our portfolio.
Dimension® EXL™ Integrated Chemistry System
- Run up to 440 photometric, 187 IMT, and 167 immunoassay tests per hour**
- Automated daily maintenance and no monthly cleaning procedures
- SARS-CoV-2 Total Antibody assay now available
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* Estimated time intervals and rates of viral detection are based on data from several published reports. Because of variability in values among studies, estimated time intervals should be considered approximations and the probability of detection of SARS-CoV-2 infection is presented qualitatively.
† These tests have not been FDA cleared or approved. They have been authorized by FDA under an EUA for use by authorized laboratories. The molecular (“PCR”) test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The serology (“antibody”) test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. The IL-6 test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID-19 patients. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.
§ This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary by country and is subject to regulatory requirements.
‡ ≥ 14 days post-PCR test.
** Testing throughput is dependent upon test mix.